Kornimate/medical-research-clean huggingface dataset:
study to assess participant/caregiver/investigator satisfaction of video-assisted telenursing in adult participants with parkinson's disease treated with levodopa-carbidopa intestinal gel

Conditions: Parkinson's Disease

Summary: parkinson's disease (pd) is a neurological condition, which affects the brain. pd gets worse over time, but how quickly it progresses varies a lot from person to person. some symptoms of pd are tremors, stiffness, and slowness of movement. the purpose of this study is to see how feasible and how satisfied participants/caregivers/investigators are with video-assisted telenursing use in nurse support programs with lcig. lcig is an approved drug to treat pd. approximately 50 adult participants with advanced pd will be enrolled in the study at approximately 10 sites across the world. the study has 2 groups. in one group, around 25 participants will receive nurse support using video devices. in the second group, around 25 participants will receive nurse support without using video devices. all participants will attend a baseline visit and follow up visits at week 4 and week 12. the planned observation period will be 12 weeks. participants who are prescribed lcig by their physicians will have three study related visits. participants, caregivers, and investigators will be asked to complete questionnaires for the study.


Eligibility criteria:
inclusion criteria: * eligible for levodopa-carbidopa intestinal gel (lcig) therapy in accordance with the approved local lcig label in the participating country * formerly lcig-naive participants who have completed an in-hospital titration, have a percutaneous endoscopic transgastric jejunostomy (peg-j) placed and are discharged from hospital * decision to treat with lcig made by the investigator prior to any decision to approach the participant to participate in this study * owns a telecommunication device equipped for videoconferencing (smart phone, tablet, laptop) * willing and able (based on investigator's judgment) to handle the video functionality of the device * caregiver willing to provide written informed consent exclusion criteria: * any condition included in the contraindications section of the approved local lcig label in the participating country * lack of caregiver support * participation in a concurrent interventional clinical trial * lack of motivation or insufficient language skills to complete the study questionnaires

Keywords: levodopa-carbidopa lcig facilitate-care
trial of transcranial direct current stimulation (tdcs)

Conditions: Major Depression

Summary: among antidepressant treatments, ect stands as the most effective in treating acute depression. however, patient concerns with the cognitive side effects of ect have encouraged the development of new and more focal forms of brain stimulation such as transcranial direct current stimulation (tdcs). however, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tdcs. this study will investigate whether tdcs stimulation using an alternative electrode montage has antidepressant effects. further sessions of tdcs, spaced less frequently, will be trialed for maintenance treatment. mood, cognitive test performance and biomarkers will be measured periodically in the duration of the trial.


Eligibility criteria:
inclusion criteria: * subject meets criteria for a dsm-iv major depressive episode. * total madrs score ≥20. exclusion criteria: * diagnosis (as defined by dsm-iv) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation. * history of drug or alcohol abuse or dependence (as per dsm-iv criteria) within the last 3 months (except nicotine and caffeine). * inadequate response to ect in the current episode of depression. * subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue. * subject requires a rapid clinical response due to inanition, psychosis or high suicide risk. * neurological disorder or insult, e.g., recent stroke (cva), which places subject at risk of seizure or neuronal damage with tdcs. * subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. * female subject who is pregnant. * participants who are not fluent in english will not be included in the trial for safety reasons: a) it is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tdcs to a subject who cannot tell us immediately of any side effects; b) as this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. this testing cannot be effectively or validly completed by someone who is not fluent in english. note that translation of the proposed tests into english has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.
mr textural analysis in low grade gliomas

Conditions: Glioma

Summary: who classification of low grade gliomas now relies on tumoral molecular patterns, especially on idh mutation and 1p/19q co deletion status. textural analysis on medical imaging is studied in several fields, and could provide help in patients with brain tumor due to possible complications of brain biopsy. the purpose of this study is to determine if specific textural signature on mr imaging could be found for low grade gliomas. the investigators included patients with lgg diagnosed at chu of nice abd whose first mri was available on the pacs of the chu. textural data are extraxted by tumoral contouring and specific logiciel (lifex) and histopathologic data are assessed for each patient. then the investigators analyze it to dtermine if textural indices can predict molecar status.


Eligibility criteria:
inclusion criteria: lgg diagnosed at chu of nice abd whose first mri was available on the pacs of the chu exclusion criteria: -
vaginal mesh procedures for female cystocele

Conditions: Cystocele

Summary: this study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

pelvic organ prolapsed (pop) is an important health issue for women all over the world, with cystocele being the commonest type of pop. the side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. the management for cystocele can be classified as non-surgical and surgical methods. non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. the perigee system (american medical systems, minnetonka, mn, usa), which has been approved by american fda and taiwan doh in treating female cystocele, have promising short-term surgical outcomes. however, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. this study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystocele exclusion criteria: * pregnancy or possibility of future pregnancy * urinary tract infection * diabetes * neurological diseases * cardiovascular diseases

Keywords: cystocele pelvic floor muscle exercise anterior vaginal repair vaginal mesh
study to evaluate the effect of eleclazine on qt, safety, and tolerability in participants with long qt2 syndrome

Conditions: LQT2 Syndrome

Summary: the primary objective of the study is to evaluate the effect of oral eleclazine (formerly gs-6615) on corrected qt (qtc) interval in participants with long qt2 syndrome.


Eligibility criteria:
key inclusion criteria: * participants with an established diagnosis of lqt2 (by genotype testing) * mean (of triplicate) qtc interval ≥ 480 msec for at least four out of seven time points, determined by standard 12-lead electrocardiogram (ecg), at screening key exclusion criteria: * known mutations associated with long qt syndrome type 1 or long qt syndrome type 3 * known or suspected history of seizures or epilepsy * history of heart failure defined as new york heart association (nyha) class iv and/or known left ventricular ejection fraction (ef) ≤ 45% * body mass index (bmi) ≥ 36 kg/m\^2 at screening * severe renal impairment at screening (defined as an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2, using the 4 variable modification of diet in renal disease (mdrd) equation), as determined by the study center * abnormal liver function tests at screening, defined as alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2 x upper limit of normal (uln), or total bilirubin \> 1.5 x uln * an aborted cardiac arrest (aca), implantable cardioverter-defibrillator (icd) implantation, syncopal episode, or appropriate icd therapy within 3 months prior to screening * any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: congenital long qt syndrome lqts sudden cardiac death
iop monitoring after trabeculectomy using icare home

Conditions: Glaucoma, Open-Angle; Pseudo Exfoliation Syndrome

Summary: the purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (iop) fluctuations measured with icare home rebound tonometry (rthome) in patients with primary open-angle glaucoma (poag) or pseudo-exfoliation glaucoma (pex).

fifty glaucoma patients (poag and pex) planned for trabeculectomy will be recruited. at baseline, patients will be trained to use the icare home tonometer (rthome), a handheld device based on rebound tonometry and designed for patients to use at home. after the training session and when patients feel confident, a measurement will be recorded. at the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. no iop values will be visible for the examiner at that point. a single iop measurement will be obtained by the same study staff using goldmann applanation tonometry (gat). patients will come for a second visit where new measurements will be made in the same way as at baseline. in between visits, patients will borrow the icare home tonometer to measure their iop at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an iop curve. two-three months after trabeculectomy, a new iop curve will be obtained following the same procedure as pre-operatively. there will be no restrictions in patients' daily activities regarding diet, physical activity or slee. if patients use any eyedrops, they will continue to use them as prescribed.

Eligibility criteria:
inclusion criteria: * poag * pxg exclusion criteria: * previous trabeculectomy * reduced hand and arm mobility (e. due to rheumatism)

Keywords: iop fluctuations icare home trabeculectomy self-tonometry
psg versus oxim-capnography to setup home niv

Conditions: COPD; OSA

Summary: the study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with ocpd-osa overlap.

with limited comparative data to support the different strategies, there is substantial variation across europe and the united states in the methods used by clinicians to set up home non-invasive ventilation (niv) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment. the investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (paco2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up niv in patients with copd-osa overlap. secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. copd-osa overlap are a patient group that have a rising prevalence with limited data currently available detailing niv set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

Eligibility criteria:
inclusion criteria: * copd (as defined by gold criteria\[4\]) * osa (odi \> 7.5 events/hr, ahi \> 5events/hr) * paco2 \> 6 kpa * bmi \> 30 kg/m2 exclusion criteria: * decompensated respiratory failure (ph \< 7.35) * inability to tolerate niv (\< 4 hours usage at in hospital titration) * contraindication to niv * pregnancy * aged \<18 * significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Keywords: sleep disordered breathing domiciliary niv
cross-training effect of whole-body vibration

Conditions: Muscle Physiology

Summary: this study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (wbv) is applied to the lower extremity. in the half of volunteers the right leg were exposed vibration, while in the other half the right leg were exposed sham vibration. muscle strength were measured with the cybex® (massachusetts, usa) extremity-testing system.

this study was included 40 healthy volunteers. the change in the quadriceps muscle strength after 20 session of wbv exercises was evaluated this study. in the wbv group, 20 sessions of unilateral lower extremity vibration exercises were performed with the whole body vibration (wbv) device. wbv was applied when the subjects are in the semi-squat position. wbv was implemented with powerplate® pro5 (powerplate® international ltd, london, united kingdom). during 20 sessions, the wbv amplitude and vibration time were increased gradually. in the first session, the subjects were do a 30-second, 30-35, 40- and 45-hz low-amplitude wbv while the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second rest period between vibration applications were applied. a total duration of wbv was be two minutes. in the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-hz high-amplitude wbv while the knee and hip joint were in 45 degrees of flexion; 10-second rest period between vibration applications were applied. a total duration of wbv was eight minutes. during wbv, the left lower extremity was in the knee-hip flexion position but was not exposed the vibration. the same experimental protocol was applied to the isometric exercise (control) group. unlike the experimental group, sham vibration was applied to the control group. before and after 20 session-exercise, both knee extensor isokinetic muscle strength was measured.

Eligibility criteria:
inclusion criteria: * men with ages between 20-50 years * being healthy * being volunteer * right-sided dominant exclusion criteria: * non-cooperative subject
a prospective observational study of the breath responsive variable bolus oxygen conserving device

Conditions: COPD

Summary: * evaluate subjects in an prospective observational study * subjects will be administered scientifically validated questionnaires * evaluate quality improvement and oxygen utilization improvements. 1. functional capability, dyspnea, oxygen saturation as primary endpoints 1. baseline dyspnea index (bdi) 2. transitional dyspnea index (tdi) 3. chronic respiratory disease questionnaire (crq) 4. six minute walk distance (6mwd) 5. oxygen saturation using pulse oximeter * the secondary endpoints: 1. portable oxygen source utilization 2. health care utilization (emergency room encounters, hospital admissions)

evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine quality improvements through using the breath responsive variable bolus oxygen conserving device with a portable/ambulatory oxygen source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Eligibility criteria:
inclusion criteria: * primary diagnosis of chronic obstructive pulmonary disease (copd) * clinically stable disease at the time of consent * current prescription of oxygen 24 hours a day * previous or current oximetry desaturation at rest or activity (≤88% on one occasion) * highest measured fev1, 70% predicted; and * highest measured fev1/fvc, 70% predicted * capable of giving informed consent * currently using a portable oxygen source that is a portable tank * mobility without a walker, cane or rollator * spo2 ≥ 90% on portable oxygen source at rest and activity * non-smoker at time of consent exclusion criteria: * cardiovascular disease - new york heart association functional class iii * degenerative bone or joint disease with limited functional ability * current homeless persons * active drug/alcohol dependence * recent drug or alcohol abuse history within the past two years * clinically unstable at the time of consent * currently a tobacco smoker

Keywords: copd ltot long-term oxygen therapy oxygen conserving device quality of life six minute walk distance portable oxygen source oxygen saturation breath responsive variable bolus oxygen conserving device brvb-ocd pulse oximetry
a non-interventional study to assess sweating

Conditions: Hyperhidrosis

Summary: to evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

this is a non-interventional study to assess sweating, as measured by gravimetry, in subjects with primary hyperhidrosis and in healthy individuals . the objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Eligibility criteria:
inclusion criteria: * females should not be pregnant or lactating. * for subjects with palmar hyperhidrosis: primary palmar hyperhidrosis of at least 6 months's duration and hyperhidrosis disease severity score of 3 or 4 at baseline * for healthy participants: no history or current report of hyperhidrosis and hyperhidrosis disease severity score of 1 at baseline exclusion criteria: * recent therapeutic interventions or treatments for palmar hyperhidrosis * any major illness within 30 days before the screening * females who are pregnant, lactating, or planning a pregnancy
mscs source of sweat gland cells of large area skin injury patients transplant of the wound

Conditions: MSCs

Summary: the main purpose of this test is to assess the umbilical cord mesenchymal stem cells (mscs) uc between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects


Eligibility criteria:
inclusion criteria: * sign the informed consent form when the age of 18 and 60 years old or less or more men or women (not pregnancy) the burned area: 10-20% tbsa, can satisfy the self control time: early for skin grafts for location: limbs, chest and back exclusion criteria: * serious allergic constitution; have influence on the speed of wound healing of chronic disease patients; according to the researcher's judgment, may endanger the safety of the subjects or scheme compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.; clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients. can not meet the requirement of the long-term follow-up of patients.
continuous glucose monitoring in peri-operative period in kidney transplant recipients

Conditions: New Onset Diabetes After Transplantation

Summary: his study aims to utilize continuous glucose monitoring (cgm) to observe glucose fluctuations in kidney transplant recipients and predict new-onset diabetes after transplantation (nodat) based on these patterns. additionally, it seeks to investigate glucose variability resulting from medications and surgeries such as immunosuppressants and steroid regimens post-kidney transplantation. this prospective observational study anticipates identifying factors influencing blood glucose levels and contributing to future research on blood glucose management using cgm monitoring in kidney transplant patients.


Eligibility criteria:
inclusion criteria: * the study will target 100 kidney transplant patients who have provided consent, among those who underwent the procedure at seoul national university hospital after march 2021. exclusion criteria: * multi-organ transplant * history of previous kidney transplant * less than 18 years old
comparative effectiveness of two initial combination therapies in patients with recent onset diabetes

Conditions: Type 2 Diabetes (Adult Onset)

Summary: the primary purpose of this study is to evaluate the efficacy, durability, and mechanism of hba1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

this is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on hba1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (t2dm) patients. a subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. the selection of subjects to each subgroup will be done randomly and the end of sub-study, subjects will continue therapy and follow-up from month 6 on in the main study.

Eligibility criteria:
inclusion criteria: 1. ability of subject to understand and the willingness to sign a written informed consent document. 2. males and females; age 18-75 years 3. recently (within 5 years) diagnosed type 2 diabetes mellitus (t2dm) patients 4. drug naïve or receiving metformin monotherapy 5. hba1c \>6.5% (no limit on upper hba1c value); 6. willingness to adhere to the investigational product regimen 7. good general health 8. stable body weight over the preceding 3 months 9. agreement to adhere to lifestyle considerations throughout study duration. exclusion criteria: 1. positive anti-gad (antibodies to glutamic acid decarboxylase) 2. pregnancy or plan of becoming pregnant 3. evidence of proliferative diabetic retinopathy, 4. plasma creatinine \>1.4 females or \>1.5 males; 5. presence of congestive heart failure (chf); 6. history of cancer (\<5 years); 7. prior history of pancreatitis, 8. bladder cancer or family history of thyroid tumors; 9. presence of hematuria in the urine analysis.